Pharmaceutical Tablet Formulation
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Questions and Answers

What is the primary purpose of controlling a tablet's general appearance?

  • To ensure lot-to-lot uniformity and consumer acceptance. (correct)
  • To maintain the tablet's chemical stability.
  • To prevent the tablet from disintegrating.
  • To enhance the tablet's therapeutic effects.

    • Which organoleptic property is essential for chewable tablets specifically?

  • Surface texture.
  • Color uniformity.
  • Taste. (correct)
  • Size.

    • What does mottling refer to in tablet production?

  • Uneven distribution of active ingredients.
  • Variability in tablet color uniformity. (correct)
  • Inconsistencies in tablet size.
  • Surface contamination during manufacturing.

    • The presence of a strong odor in a batch of tablets is likely an indicator of what?

    <p>A stability problem in the tablet formulation.</p> Signup and view all the answers

    What factor does NOT influence consumer acceptance of tablets?

    <p>Detailed formulation specifications.</p> Signup and view all the answers

    Which attribute is NOT typically measured to assess a tablet's general appearance?

    <p>Consumer reviews.</p> Signup and view all the answers

    What is the significance of unique identification markings on tablets?

    <p>To facilitate rapid identification and prevent counterfeiting.</p> Signup and view all the answers

    What is the primary cause of capping and lamination in tablet production?

    <p>Deformational properties of the formulation during compression</p> Signup and view all the answers

    What is a consequence of excessive die-wall pressure during compaction?

    <p>Crack initiation leading to fracture</p> Signup and view all the answers

    How does the relaxation of shear stresses relate to tablet fracture occurrence?

    <p>It is time-dependent and can result in delayed fracture.</p> Signup and view all the answers

    Which factor is NOT associated with capping and lamination issues in tablets?

    <p>Strong binder formulation</p> Signup and view all the answers

    What additional factor can contribute to lamination beyond the previously discussed causes?

    <p>Over compression leading to particle flattening</p> Signup and view all the answers

    What could result from inconsistent tablet thickness between batches?

    <p>Content uniformity issues</p> Signup and view all the answers

    What is the acceptable variation in tablet thickness during manufacturing?

    <p>± 5%</p> Signup and view all the answers

    Which factor does NOT affect tablet hardness during the manufacturing process?

    <p>Type of packaging used</p> Signup and view all the answers

    What happens to tablet hardness when the die fill increases while maintaining constant compression force?

    <p>It increases</p> Signup and view all the answers

    What is measured using a micrometer caliper in tablet evaluation?

    <p>Tablet thickness</p> Signup and view all the answers

    What could be a consequence of tablet thickness exceeding the allowable variation?

    <p>Potential packaging issues</p> Signup and view all the answers

    Which of the following best describes the tablet hardness test?

    <p>It determines the force needed to break the tablet</p> Signup and view all the answers

    Which tester is used to assess tablet crushing strength?

    <p>Monsanto hardness tester</p> Signup and view all the answers

    What effect does increased compression force have on tablet thickness?

    <p>It decreases thickness</p> Signup and view all the answers

    What is the primary purpose of the friability test in tablet evaluations?

    <p>To ensure tablets remain intact during mechanical pressure</p> Signup and view all the answers

    What is the maximum weight loss expected for conventional compressed good tablets in a friability test?

    <p>1%</p> Signup and view all the answers

    Which of the following tests is NOT listed as an official USP test for tablet evaluation?

    <p>Hardness test</p> Signup and view all the answers

    Which equipment is identified as the laboratory friability tester?

    <p>Roche friabilator</p> Signup and view all the answers

    What does the content uniformity test measure in tablet evaluation?

    <p>The amount of drug per tablet</p> Signup and view all the answers

    What common factor can lead to weight variation in tablets?

    <p>Poor flow of tablet formulation</p> Signup and view all the answers

    Which factor is NOT impacted by the tablet's friability?

    <p>Drug release rate</p> Signup and view all the answers

    What is the significance of monitoring drug content per tablet from batch to batch?

    <p>To ascertain the efficacy of the tablet</p> Signup and view all the answers

    At what revolutions per minute does the Roche friabilator operate during testing?

    <p>25 rpm</p> Signup and view all the answers

    Which of the following describes a consequence of tablets that powder, chip, or fragment easily?

    <p>Reduced marketability</p> Signup and view all the answers

    What is the maximum percentage difference allowed for a tablet weighing more than 324 mg?

    <p>±5 %</p> Signup and view all the answers

    Which of the following is NOT a direct contributor to content uniformity problems in tablets?

    <p>Inadequate tablet hardness</p> Signup and view all the answers

    During a weight variation test, what percentage of tablets must be within 85%-115% of the theoretical drug content?

    <p>9 of 10 tablets</p> Signup and view all the answers

    What is the time requirement for an enteric-coated tablet to remain intact in the USP disintegration apparatus?

    <p>1 hour</p> Signup and view all the answers

    Why is the weight variation test of limited importance for very potent drugs?

    <p>Because the effective dose is very small</p> Signup and view all the answers

    What is the typical disintegration time limit for standard tablets according to the USP?

    <p>30 minutes</p> Signup and view all the answers

    Which issue can indicate a problem with tablet manufacturing processes related to weight variation?

    <p>Inconsistent drug distribution</p> Signup and view all the answers

    What should be the percentage range for only one of the tablets during a content uniformity test?

    <p>75% - 125%</p> Signup and view all the answers

    In conducting the disintegration test, which factor is primarily evaluated?

    <p>Tablet breakdown time</p> Signup and view all the answers

    For tablets weighing 130 mg or less, what is the allowable maximum percentage difference in weight?

    <p>±10 %</p> Signup and view all the answers

    Study Notes

    Tablet Evaluations

    • Tablets are a unit dosage form, easy to handle, store, and dispense.
    • Manufacturing cost is lower compared to other dosage forms.
    • Release profile is easily controlled and manipulated.
    • Some drugs resist compression, not ideal for masking bad taste or smell.
    • Difficulty formulating drugs with poor wetting properties.
    • Some drugs degrade when taken orally.

    Types of Tablets

    • Various types, including vaginal, cough lozenges, and enteric-coated aspirin.
    • Visual examples are provided in the slides.

    Granulation

    • Fine powder drugs generally have poor flow properties.
    • Granules have better flowability and compressibility than individual ingredients.
    • Granulation ensures consistent API spread in the formulation.

    Compression

    • The final step in tablet formulation.
    • Requires variables beyond the scope of the course.
    • Diagram of the compression process is shown.

    Tablet Evaluation

    • General appearance is critical for consumer acceptance, lot-to-lot uniformity, tablet-to-tablet uniformity, and trouble-free manufacturing.
    • General appearance involves measuring factors like size, shape, color, odor, taste, texture, physical flaws, consistency, and legibility of markings

    Unique Identification Markings

    • Used for quick product identity.
    • Information typically includes company name, product code, potency.
    • Tablet prints must be clear and flaw-free.
    • Examples of different tablet prints are given.

    Organoleptic Properties

    • Color is vital for rapid identification and consumer acceptance, must be uniform.
    • Mottling (non-uniform color) may negatively affect patient acceptance.
    • Odor can indicate stability problems, as seen in aspirin degradation.
    • Taste is important, especially for chewable tablets.
    • Visual flaws like chips, cracks, or foreign bodies, affect patient acceptance.
    • Surface texture (smooth/rough) and appearance (shiny/dull) are also assessed.

    Size and Shape

    • Tablet shape and diameter are determined by the die shape.
    • Tablet thickness is the only dimensional variable related to the process.
    • Thickness should be consistent across batches.
    • Inconsistent thickness can indicate content uniformity problems, affect patient acceptance, and lead to packaging issues.
    • Thickness is measured with a micrometer caliper.
    • Thickness variation should not exceed ± 5%.

    Tablet Hardness (Non-Official)

    • Tablets must withstand mechanical stress during manufacturing, packaging, shipping, and handling.
    • Tablet hardness is related to disintegration time.
    • Hardness can be varied by die filling, compression force, and binder amount.
    • Testing involves measuring the force to break a tablet.

    Tablet Friability (Official USP)

    • Hardness is not the sole measure of good tablets; friability is also needed.
    • A friability test evaluates a tablet's resistance to mechanical stress.
    • Tablets that crumble or fragment when handled lack consumer acceptance.
    • Roche friabilator, a laboratory device used for the test.
    • Conventional compressed tablets should lose less than 1% of their weight.

    Drug Content and Release

    • A physically sound tablet may not always deliver the desired effects.
    • Measuring drug content per tablet and batch is essential.
    • Measuring a tablet's ability to release the drug is important.
    • Official USP tests include weight variation, content uniformity, disintegration, and dissolution testing.

    Weight Variation (Official USP)

    • Weight of tablets must be within USP weight variation limits.
    • Factors leading to weight variation include poor flow and machine setup.

    Content Uniformity Test (Official USP)

    • Ensures active pharmaceutical ingredients are evenly distributed within the tablet, within the limit.

    Disintegration Test (Official USP)

    • Measures the time it takes for a tablet to break down into smaller particles.
    • Usually, tablet disintegration should happen in under 30 minutes.
    • Enteric-coated tablets need longer disintegration time (at least 1 hour).

    Dissolution Test (Official USP)

    • Measures how quickly the drug dissolves to be absorbed by body.
    • The drug in solution is readily absorbed.
    • Dissolution results are plotted as % release versus time.
    • A simulation apparatus, USP dissolution apparatus is commonly used.

    Importance of Dissolution Testing

    • Guides formulation and product optimization.
    • Monitors manufacturing quality.
    • Ensures bioequivalence of batches.
    • Facilitates regulatory approval for marketing.

    Processing Problems

    • Final tablet formulation can undergo problems after being compressed, packaged, shipped, stored, and handled.
    • Problems can arise from manufacturing, excipients, or both.
    • Capping: partial or complete separation of the tablet's top or bottom crown from the main body.
    • Lamination: complete separation into multiple layers.
    • These may occur immediately after compression or hours/days later.
    • Capping/lamination issues are related to air entrapment during compression or deformation properties during compression.

    Causes of Capping and Lamination

    • Air entrapment during compression.
    • Deformational properties of the formulation during or immediately after compression.
    • Incorrect excipient choices especially the binder.
    • Granule dryness can cause cohesion issues.
    • Poor compression machine setup.

    Deformational Changes (Causes of Capping and Lamination)

    • Compaction creates wall pressure higher than the elastic recovery from pressure removal.
    • This leads to cracks, and fractures upon decompression.
    • Portion of the compact expands causing shear stress.
    • Tablets that don't fracture have stress relaxation; therefore, fracture happens later over time.
    • Over compression
    • Tablet thickness can cause binding problems.

    Solution for Capping and Lamination

    • Slowing compression speed and reducing pressure allows air escape.
    • Pre-compression steps with gentler force pre-form the tablet.
    • Selecting the correct excipients.
    • Using another tablet shape, like a flat-end, has lower fracture tendency.
    • Deep concave punch shape that expands the tablet surface may cap the tablet.
    • Cracking, due to rapid tablet expansion after compression, or poor granulation (dryness), or cold environment.
    • Solution: improve tablet formulation, and optimize binder usage during granulation.
    • Chipping: breaking edges due to poor particle flow (lack of lubrication).
    • Sticking: tablet material sticking to die/punch faces or the machine.
    • Picking: small portion of tablet surface sticking to the punch faces.
    • Mottling: unequal color distribution related to use of dyes or degradation.

    Solutions (Excipient Problems)

    • Adjust lubricant amount.
    • Improve granule drying.
    • Properly designing lettering depth and position.
    • Adjust solvent system/ properly granulate the dye.
    • Avoid large chunks of dye.

    Other Problems

    • Weight variation: Tablets with weights outside the USP limits.
      • Die filling problems: Variations in lower punch length.
      • Granule size and distribution variations.
      • Poor flow: Insufficient lubricant.
      • Poor hooper design.
    • Poor mixing: Insufficient lubricant or glidant distribution.
    • Double impression: Punch rotating slightly during compression.
    • Uneven breakage: Caused by coarse granules and improper mixing.

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    Description

    This quiz covers the essential aspects of pharmaceutical tablet formulation, including the types of tablets, granulation, and compression processes. Understanding tablet evaluation and characteristics is crucial for ensuring consumer acceptance and effective drug delivery. Test your knowledge on the manufacturing and formulation of tablets.

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